“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era. To be very brief, Jurisfiction is the fictional police force for BookWorld, one of Fforde’s fictional universes. Tuesday is a Jurisfiction agent (sometimes rather more than that).
“Jurisfiction,” unfortunately, is also something we see in our line of work, sometimes making us wonder whether the likes of Emperor Zhark, the Red Queen, and Pinky Perkins may have aliases who serve in the all-too-real judicial branches here in the States. Jurisfiction is shorthand for a decision that gets a legal issue totally bollixed – perhaps applying the UltraWord to the issue – allowing the user to control the plot, garbling it, and ultimately making all precedent useless.
We recently ran across a shining example of jurisfiction in the discussion of FDA warning letters found in Mihok v. Medtronic, Inc., ___ F. Supp.3d ___, 2015 WL 4722847 (D. Conn. Aug. 10, 2015). Here’s what Mihok held on that subject:
The Complaint is rooted in FDA Warning Letters which state that [defendant] failed to comply with the CGMP regulations. . . . While perhaps not dispositive on the issue, the FDA’s conclusions and interpretations of its own regulations are likely to receive a considerable degree of deference. See, e.g., Conroy v. Dannon Co., Inc., No. 12 CV 6901(VB), 2013 WL 4799164, at *6 (S.D.N.Y. May 9, 2013) (stating that the FDA’s interpretations of its own regulations promulgated under title 21 “are ‘controlling unless plainly erroneous or inconsistent with the regulations’ or there is any other reason to doubt that they reflect the FDA’s fair and considered judgment”) (citing and quoting PLIVA, Inc. v. Mensing, ––– U.S. ––––, ––––, 131 S.Ct. 2567, 2575, 180 L.Ed.2d 580 (2011)); Dorsey v. Housing Auth. of Baltimore City, 984 F.2d 622, 632 (4th Cir. 1993) (finding district court abused its discretion in refusing to consider regulatory agency’s assessment of defendant’s compliance with agency regulations and noting that the district “court should welcome [the agency’s] appraisal of [the defendant’s] compliance with regulations, given its concern for deference to agency interpretations of its own regulations”). Indeed, it is precisely when a court is called upon to interpret the regulations, i.e., when they are ambiguous, and where their application to facts raises complex issues, that the court is most likely to defer to the FDA’s prior determinations. See Wilson v. Frito-Lay N. Am., Inc., 961 F. Supp.2d 1134, 1142 (N.D. Cal. 2013) (noting that “an agency’s informal interpretation of its own ambiguous regulation is [typically] controlling” but declining to give “deference to two warning letters that the FDA sent” because neither party to the case “contended that the FDA regulations . . . [w]ere ambiguous, and the Court d[id] not find that they [we]re”); James T. O’Reilly, et al., 1 Food & Drug Admin. §4:56 (4th Ed. 2015) (“The FDA is allowed great deference in the interpretations of its own regulations…. The more complex the issue, the more scope is likely to be given for the FDA to draw the interpretations.”).
As to deference, Defendants cite a non-binding case, Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939 (E.D. Wisc. 2008), for the proposition that “a warning letter from the FDA is not considered a final agency action,” and contend that, as a result, “Plaintiffs’ allegations … raise legal questions as to the potential effects of various actions by a federal agency … [which] should be decided in a federal forum.” The Second Circuit has not taken a position on whether an FDA Warning Letter is considered a final agency action. Even if it is not, such letters may still be entitled to deference. See Cmty. Health Ctr. v. Wilson-Coker, 311 F.3d 132, 138 (2d Cir. 2002) (“[E]ven relatively informal [agency] interpretations, such as letters from regional administrators, warrant respectful consideration” where the statute at issue is complex and the regulatory agency possesses “considerable expertise”) (citations and quotations omitted). Regardless, they may serve as evidence of regulatory violations. Gelber v. Stryker Corp., 788 F. Supp.2d 145, 155–56 (S.D.N.Y. 2011) (finding plaintiffs who provided FDA Warning Letters as evidence of violations of FDA regulations stated claims for manufacturing defects).
Mihok, 2015 WL 4722847, at *5-6 (citations not omitted, for once). Under this analysis, there being no undecided FDA-related issue, Mihok was remanded to state court.